Chymotrypsin Tablets

Description

Trypsin–Chymotrypsin Tablets (100,000 Armour Units)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Trypsin–Chymotrypsin enteric-coated tablets in India. These proteolytic enzyme formulations are used in some markets as adjunctive therapy for inflammatory swelling and edema associated with trauma, surgery and other selected conditions. Because proteolytic enzymes can lose activity in acidic environments, enteric coating is used to protect the tablet during gastric transit and provide release according to the validated formulation. Healthy Inc manages international export logistics.

2. Product Specifications

3. Manufacturing Technology

• Enteric Protection: A validated enteric-coating system is used to resist release in acidic conditions and provide release at the intended intestinal pH according to the product specification.
• Temperature & Moisture Control: Processing conditions are controlled because enzyme activity can be affected by heat and moisture.
• Potency Verification: Enzyme preparations are standardized by biological activity, and finished-product testing verifies activity against the approved specification.
• The Exporter: Healthy Inc. Packaging configurations can be supplied according to registration, tender and destination-market requirements.

4. Quality Assurance

• Enzymatic Activity: Proteolytic activity is tested using the applicable validated or compendial method.
• Enteric-Coating Performance: The product is evaluated using appropriate acid-resistance and subsequent release testing according to the registered specification.
• Microbial Quality: Non-sterile oral products are tested against applicable microbial-limit requirements.
• Stability: Activity and relevant quality attributes are monitored through the assigned shelf life.

5. Why Use Trypsin–Chymotrypsin?

Trypsin and Chymotrypsin are proteolytic enzymes. Oral enzyme combinations are used in some countries as adjunctive treatment for inflammatory edema and swelling; their approved indications and evidence base can vary by market.

Key Uses:

• Post-Traumatic Swelling: May be prescribed as an adjunct for swelling associated with soft-tissue injury or trauma.
• Post-Operative Edema: May be used as part of post-operative management when clinically appropriate.
• Dental / Orthopedic Procedures: Use may be considered according to local approved indications and clinician judgment.
• Infection-Related Conditions: Enzyme tablets do not replace antibiotics, drainage or other definitive treatment when infection or abscess is present.

6. Export and Regulatory Support

• Dossier Support: CTD and ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to commercial and regulatory requirements.

7. Frequently Asked Questions

Q: Who manufactures Chymotrypsin / Trypsin–Chymotrypsin Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures the formulation in India.

Q: Is Cirozyme – 1 a Trypsin–Chymotrypsin combination?
A: Yes. The supplied formulation provides 100,000 Armour Units of enzymatic activity from purified Trypsin and Chymotrypsin concentrate in an approximate 6:1 activity ratio.

Q: Should the enteric-coated tablet be chewed or crushed?
A: No. Unless the specific product label states otherwise, enteric-coated tablets should be swallowed whole because damaging the coating can alter where the enzymes are released.

Q: Is this a painkiller?
A: It is not a conventional analgesic such as paracetamol or an NSAID. It is an enzyme formulation used as an adjunct for selected inflammatory swelling/edema indications in markets where approved.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Dosage, frequency and duration should follow the approved product label and prescriber’s instructions because enzyme activity strengths and approved regimens can differ between products and markets.
• Administration: Swallow the enteric-coated tablet whole. Do not chew or crush it.
• Food Timing: Follow the specific registered product instructions regarding administration in relation to meals rather than assuming a universal empty-stomach schedule.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, diarrhea, abdominal discomfort or other gastrointestinal symptoms may occur.
• Allergy: Hypersensitivity reactions are possible, particularly in patients sensitive to the enzyme source or other formulation components.
• Bleeding Risk: Patients with bleeding disorders or those taking anticoagulant/antiplatelet medicines should seek medical advice before use.
• Liver / Kidney Disease: Significant hepatic or renal disease requires clinical assessment before use.
• Pregnancy / Breastfeeding: Use should be based on medical assessment because safety data may be limited for specific formulations.

10. Storage Instructions

• Store below 25°C in a cool, dry place.
• Protect from moisture and excessive heat.
• Keep in the original packaging until use.
• Keep out of reach of children.